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oc631

11/27/12 4:29 AM

#153004 RE: genisi #153002

Hi Idit....I was hoping to get your input.


Do you think the rumored pivotal study design would be sufficiently powered for the FDA to accept a BLA filing without a SPA?

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oc631

11/27/12 4:31 AM

#153005 RE: genisi #153002

these are not the conditions for the future phase III trial.




Has the company released details on the design?